FDA.reportPublic FDA data

BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables

Primary DI
68888893501323
Brand
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables
Company
BIOPTIMAL INTERNATIONAL PTE. LTD.
Model
CM-BT201 (MEDTRANS II)
Catalog number
BL-0003-008
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRSTransducer, Blood-Pressure, Extravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
68888893501323PackageGS172In Commercial Distribution
08888893501321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
6888889350132368888893501323
08888893501321088888935013218888893501321

GMDN Terms#

Term, Definition table
TermDefinition
Invasive-pressure external transducer, reusableA noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark cool dry places

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+6562135777Sales_CCP@biosensors.com

Regulatory Flags#

DUNS number
595182247
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08886483551640Thermodilution Catheter and AccessoriesTD1755HD21-000153-502026-05-20
08886483551657Thermodilution Catheter and AccessoriesTD2755NDF21-000202-452026-05-20
08886483551664Safewedge(TM) Relief Valve DeviceSafetywedge21-000212-012026-05-20
08886483500174Thermodilution Catheter and AccessoriesTD2604NXF21-000009-582026-05-04
08886483500181Thermodilution Catheter and AccessoriesTD2604NDXF21-000009-592026-05-04
08886483500372Thermodilution Catheter and AccessoriesTD2504NXF21-000046-432026-05-04
08886483500389Thermodilution Catheter and AccessoriesTD2504NDXF21-000046-442026-05-04
08886483501508Thermodilution Catheter and AccessoriesTD2704NDF21-000201-162026-05-04
08886483501515Thermodilution Catheter and AccessoriesTD2704NCXF21-000201-172026-05-04
08886483501546Thermodilution Catheter and AccessoriesTD2755NX21-000202-002026-05-04
08886483501553Thermodilution Catheter and AccessoriesTD2755NDF21-000202-012026-05-04
08886483501577Thermodilution Catheter and AccessoriesTD2755NDX21-000202-032026-05-04
08886483501584Thermodilution Catheter and AccessoriesTD2755NDPXF21-000202-042026-05-04
08886483502390BIOTRANS™ Pressure Monitoring KitsBTR4812-322-000813-232026-05-04
08886483503151BIOTRANS™ Pressure Monitoring KitsEXTENSION TUBING SET22-000895-962026-05-04
08886483503748ACCUTRANS Disposable Pressure Monitoring KitAT W/O IFU(BNS)22-000940-022026-05-04
08886483504455Embolectomy CatheterEL144023-000006-152026-05-04
08886483504486Embolectomy CatheterEL158023-000006-182026-05-04
08886483504516Embolectomy CatheterEL154023-000006-212026-05-04
08886483507005BIOTRANS™ Reusable Sensor Base and Monitor Adapter CablesBT-201BL-0003-0182026-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483502390BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503151BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503748ACCUTRANS Disposable Pressure Monitoring KitBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483507005BIOTRANS™ Reusable Sensor Base and Monitor Adapter CablesBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
H6713000060N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000120N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000180N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000240N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000360N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000480N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000600N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000720N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000840N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100060N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100120N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100180N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100240N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100360N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100480N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100600N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100720N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100840N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6716001010N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6716001020N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6716001220N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6716004000N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6719004920DELTRANUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6719015960DELTRANUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6719020080DELTRANUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6719020110DELTRANUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23